Signs of mild cognitive impairment (MCI) or memory loss may include

• Misplacing things often
• Difficulty finding words to describe objects and/or express feelings
• Forgetting to attend important events
• Trouble reading, writing, and/or holding conversations
• Repeating the same questions or stories
• Feeling lost or disoriented in familiar places
• Neglecting financial tasks, such as paying bills

You may consider applying, or a loved one can apply on your behalf with your consent if you

• Are between the ages of 50 and 85 years old
• Are experiencing signs of memory loss, and may or may not have been diagnosed with mild cognitive impairment or dementia
• Have a caregiver or partner willing to assist with participation in the study and who can attend study visits with you

The information gleaned from this study may help find new treatment options in the future for people with memory problems, such as those living with mild cognitive impairment or dementia. Your condition will be checked as long as your participation in the study lasts. However, services provided and evaluations carried out as part of the study should not be seen as a substitute for a careful evaluation, ongoing medical care, or follow up by your family/personal doctor.

No, there is no cost to participate. Eligible participants do not pay for the study medication, clinic visits, or study-related medical procedures and laboratory tests. You will be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research study visit.

As all drugs and medical procedures carry a risk of side effects, the possibility that participants may experience some discomfort or other reactions does exist. The study staff will explain these potential risks before you decide whether to participate and address any concerns.

Participation is entirely voluntary. Even if you are already involved in the clinical trial, you can change your mind at any time and for any reason.

We are evaluating an investigational drug called XPro1595. This targets a protein called soluble TNF and it is designed to target a process called inflammation in the brain of people with early and mild Alzheimer’s Disease. In this study, we will be evaluating how safe and tolerable XPro1595 is, how it is processed by the body, and its potential as a new therapeutic in dementia.

Participants who meet all study requirements will be randomly assigned to receive either XPro1595 or placebo. The placebo has no active medication. In total, this study will involve several visits over a period of six months. Study drug administration may be conducted either in your home or at the clinic for certain visits.  During the clinic visits, participants will have a safe, caring environment so study partners can feel confident their loved ones are being treated with compassion and respect.

Before a potential participant decides whether to take part in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by both the participant and caregiver or partner, the screening period of the study begins. During this period, the staff will review medical history and conduct a series of study-related exams, lab tests, and scans to see whether the cause of memory changes is due to early Alzheimer’s. Those who meet all of the study requirements will be offered to participate.

Participants who meet all study requirements will be randomly assigned to receive one to three doses of either XPro1595 or placebo. The placebo has no active medication. In total, this study will involve nine visits over a period of about six months. Some participants may stay overnight at the study center for one to two nights. During the visits, participants will have a safe, caring environment so caregivers or partners can feel confident their loved ones are being treated with compassion and respect.

The chance of receiving the placebo will be 34% or less.

A: If you are interested in learning more, please contact us at any time. You may email us at help@clinicalenrollment.com.

After finishing the study, participants may consider participating in future clinical studies, or enter the open label extension of XPro1595 in which all participants will receive XPro1595 (there is no placebo in the open label extension).